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NCT Number: NCT07151729

Use of Anodal tDCS to Enhance Upper Limb Recovery in Stroke

This will be a randomized, blinded, sham-controlled trial. The medical device used, Soterix Medical 1x1 tDCS stimulator, is capable of delivering either real or sham tDCS and has been used in many randomised controlled trials in stroke patients.

50 patients with subacute stroke and severe upper limb weakness within 8 weeks of stroke on transfer to TTSH stroke rehab wards will be recruited over a period of 10 months. Recruited patients will be randomized into the intervention and control arms in a 1:1 ratio.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital - Integrated Care Hub

Singapore, 307382

Location status: Recruiting

Location contact

WAI PING ALFRED SENG

PRINCIPAL_INVESTIGATOR

WAI PING ALFRED SENG, MBBS, MRCP

CONTACT

[email protected]

+65 68894580

About this study

The primary objective is to determine the clinical efficacy, technical feasibility and safety of anodal tDCS therapy to the unaffected hemisphere in hospitalized subacute stroke patients with severe arm weakness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First ever unilateral ischaemic or haemorrhagic stroke, as documented by CT or MRI scans
  • Age 21-80 years, both males and females
  • Within 8 weeks of stroke onset
  • Severe weakness of one upper limb, defined by a Shoulder Abduction and Finger Extension (SAFE) score < 5 (Medical Research Council grading)
  • Provision of informed consent by patient or a legal guardian in accordance with the local ethics committee guidelines and the Declaration of Helsinki

Exclusion criteria

  • Bilateral hemispheric or cerebellar strokes
  • Pre-existing arm pathology (e.g. contracture, severe pain, etc.) on the affected side
  • Presence of brain implants, and previous insertion of external ventricular drains.
  • Metallic implants at the level of the neck, mouth cavity and below are permitted (e.g. Cardiac stents, dental implants, pacemakers and other metallic objects)
  • A history of spontaneous seizures, epilepsy, brain tumour, and cranial surgery
  • Severe cognitive impairment (MOCA Score <10) that would hinder sufficient understanding of the instructions
  • Pregnancy

Treatment and study plan

Anodal tDCS

Device

This anodal tDCS is applied over the contralateral dorsal premotor cortex (instead of the ipsilateral motor cortex in previous studies).

Other names: tDCS

Sham tDCS

Device

Sham tDCS is applied

Other names: tdcs

Primary outcomes

  1. Fugl-Meyer Upper Limb

    Time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)

    Fugl-Meyer Upper Limb

Secondary outcomes

  1. Streamlined Wolf Motor Function Test (sWMFT)

    Time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10) At 3 months after the 10th tDCS session (Month 3)

    Streamlined Wolf Motor Function Test (sWMFT)

  2. Functional Independence Measure (FIM)

    Time frame: At baseline (Day 0) At end of 10 tDCS sessions (Day 10)

    Functional Independence Measure (FIM) is a widely used objective assessment tool in rehabilitation to evaluate a patient's functional abilities and track their progress. It is a 18-item, 7-level scale, with higher scores indicating greater independence. The total FIM score ranges from 18 to 126.

  3. EQ5D-5L

    Time frame: At baseline (Day 0) and at 3 months after the 10th tDCS session (Month 3)

    The EurolQol 5-Dimension 5-Level (EQ5D-5L) is a widely-used, non-disease specific questionnaire designed to assess a patient's health related quality of life. It serves as a patient-reported outcome instrument, capturing the patient's own perspective on their health. It consists of a descriptive system of five questions (each scored from Level 1 to 5, with a higher score indicating more severe problems) and a visual analogue scale (VAS) for overall health assessment. A higher VAS (from 0 to 100) would indicate a better quality of life.

  4. Rate of Adverse Events from tDCS

    Time frame: Immediately after each tDCS session (total 10 sessions of tDCS)

    An adverse events questionnaire is administered immediately after each tDCS session. As such, each participant would fill up 10 adverse effects questionnaires after a total of 10 tDCS sessions.

    The rate of adverse events from tDCS would be computed from the number of adverse events divided by the total number of tDCS sessions.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Ng Teng Fong Healthcare Innovation Programme

Registry information

Official study title

Use of Anodal Transcranial Direct Current Stimulation to Enhance Upper Limb Recovery in Stroke

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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